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ABBV-243

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Last Updated: Jan 12, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-243 · 1 trial · 1 indication

Phase 1 1
NCT07306754A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.Healthy Volunteers
RECRUITING66 Analytics
PHASE1RECRUITING
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
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Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AEs)
Up to Day 204

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Maximum Observed Serum Concentration (Cmax) of ABBV-243
Up to Day 204

Maximum observed serum concentration (Cmax) of ABBV-243

Time to Cmax (Tmax) of ABBV-243
Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243
Up to Day 204

Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243

Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243
Up to Day 204

AUC from time 0 to infinite time (AUCinf) of ABBV-243

Terminal Phase Elimination Rate Constant (β) of ABBV-243
Up to Day 204

Terminal phase elimination rate constant of ABBV-243

Terminal Phase Elimination Half-Life (t1/2) of ABBV-243
Up to Day 204

Terminal phase elimination half-life of ABBV-243

Anti-Drug Antibody (ADA) of ABBV-243
Up to Day 204

Confirmed Positive ADA Results.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group 1: ABBV-243 or PlaceboEXPERIMENTALParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
Group 2: ABBV-243 or PlaceboEXPERIMENTALParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
Group 3: ABBV-243 or PlaceboEXPERIMENTALParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
Group 4: ABBV-243 or PlaceboEXPERIMENTALParticipants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
Group 5: ABBV-243 or PlaceboEXPERIMENTALParticipants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
Group 6: ABBV-243 or PlaceboEXPERIMENTALParticipants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
Group 7: ABBV-243 or PlaceboEXPERIMENTALHan Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
Group 8: ABBV-243 or PlaceboEXPERIMENTALJapanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Interventions

NameTypeDescription
ABBV-243DRUGIntravenous (IV) Infusion
PlaceboDRUGIntravenous (IV) Infusion
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Individuals between 18 and 60 years of age inclusive at the time of Screening. * BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Females, Non-Childbearing ...

Countries:United States
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Frequently asked questions about ABBV-243

What is ABBV-243 used for?

ABBV-243 is an investigational small molecule being studied in healthy volunteers. It is currently in a Phase 1 clinical trial to evaluate its safety and pharmacokinetics. The drug is not approved for any condition and is in early-stage clinical development.

Who makes ABBV-243?

ABBV-243 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting a Phase 1 study of the drug in healthy adults in the United States.

What phase is ABBV-243 in?

ABBV-243 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety and pharmacokinetics in healthy adults.

What clinical trials is ABBV-243 in?

ABBV-243 is being studied in a single Phase 1 clinical trial with the identifier NCT07306754. This randomized, double-blind, controlled study is evaluating the safety and pharmacokinetics of ABBV-243 in healthy adults. The trial is recruiting 66 participants in the United States.

Is ABBV-243 a small molecule?

Yes, ABBV-243 is a small molecule drug. It is being developed as an oral or injectable therapeutic, though the specific route of administration is not specified. The drug is in Phase 1 testing to evaluate its safety and how the body processes it.